p16/Ki67 免疫组化、HPV E6/E7 mRNA 检测和 HPV DNA 检测在 ASCUS 女性中检测高级别宫颈上皮内瘤变的性能。
Performance of p16/Ki67 immunostaining, HPV E6/E7 mRNA testing, and HPV DNA assay to detect high-grade cervical dysplasia in women with ASCUS.
机构信息
Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Zhengzhou University, No. 7, Front Kangfu Street, Zhengzhou, 450052, Henan Province, People's Republic of China.
Department of Imaging, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, People's Republic of China.
出版信息
BMC Cancer. 2019 Mar 27;19(1):271. doi: 10.1186/s12885-019-5492-9.
BACKGROUND
Atypical squamous cell of undetermined significance (ASCUS) is a common cervical cytological diagnosis. At present, HPV DNA assay is used to triage these patients, but its lower specificity brings a series of problems. The purpose of this study was to evaluated the value of p16/Ki67 immunostaining, HPV E6/E7 mRNA testing in triaging women with ASCUS by comparing HPV DNA assay.
METHODS
Liquid based cytology specimens were collected from 300 patients. P16/Ki67 immunocytochemistry using the CINtec® Plus Kit and HPV E6/E7 mRNA testing by QuantiVirus®HPV E6/E7 mRNA assay used the same cytology sample. Detection rates of each test were evaluated against histopathology.
RESULTS
All assays yielded a high sensitivity for the detection of CIN3+ (100% (86.7-100) for HPV DNA assay, 88.0% (70.0-95.8) for HPV E6/E7 mRNA testing and 100% (86.7-100) for p16/Ki67 immunocytochemistry) and CIN2+ (98.2% (90.2-99.7) for HPV DNA assay, 87.0% (75.6-93.6) for HPV E6/E7 mRNA testing, 98.2% (90.2-99.7) for p16/Ki67 immunocytochemistry). The specificity to detect high grade dysplasia was highest for p16/Ki67 immunocytochemistry (74.2% (68.7-79.0) in CIN3+ and 82.5% (77.3-86.8) in CIN2+), followed by HPV E6/E7 mRNA testing (39.6% (34.0-45.5) in CIN3+ and 42.7% (36.7-48.9) in CIN2+) and HPV DNA assay (16.0% (12.1-20.8) in CIN3+ and 17.5% (13.2-22.7) in CIN2+).
CONCLUSIONS
p16/Ki67 immunostaining and HPV E6/E7 mRNA testing, especially the former, may be promising tools in triage of ASCUS.
背景
非典型鳞状细胞意义不明确（ASCUS）是常见的宫颈细胞学诊断。目前，HPV DNA 检测用于对这些患者进行分流，但它的特异性较低带来了一系列问题。本研究旨在通过比较 HPV DNA 检测评估 p16/Ki67 免疫染色、HPV E6/E7 mRNA 检测在 ASCUS 患者分流中的价值。
方法
收集 300 例患者的液基细胞学标本。使用 CINtec®Plus 试剂盒进行 p16/Ki67 免疫细胞化学染色，使用 QuantiVirus®HPV E6/E7 mRNA 检测试剂盒进行 HPV E6/E7 mRNA 检测，使用相同的细胞学样本。根据组织病理学评估每种检测方法的检测率。
结果
所有检测方法对 CIN3+的检测均具有较高的敏感性（HPV DNA 检测 100%（86.7-100），HPV E6/E7 mRNA 检测 88.0%（70.0-95.8），p16/Ki67 免疫细胞化学染色 100%（86.7-100））和 CIN2+（HPV DNA 检测 98.2%（90.2-99.7），HPV E6/E7 mRNA 检测 87.0%（75.6-93.6），p16/Ki67 免疫细胞化学染色 98.2%（90.2-99.7））。检测高级别发育不良的特异性以 p16/Ki67 免疫细胞化学染色最高（CIN3+为 74.2%（68.7-79.0），CIN2+为 82.5%（77.3-86.8）），其次是 HPV E6/E7 mRNA 检测（CIN3+为 39.6%（34.0-45.5），CIN2+为 42.7%（36.7-48.9））和 HPV DNA 检测（CIN3+为 16.0%（12.1-20.8），CIN2+为 17.5%（13.2-22.7））。
结论
p16/Ki67 免疫染色和 HPV E6/E7 mRNA 检测，尤其是前者，可能是 ASCUS 患者分流的有前途的工具。
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